Turkey titck kymriah ruhsat?

When did Kymriah receive marketing authorization in Turkey?

Marketing authorization for Kymriah (tisagenlecleucel) in Turkey was granted in November 2020 [1]. This approval covers the treatment of pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in relapse, as well as adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1].

What is Kymriah and how does it work?

Kymriah is a type of gene therapy called a CAR-T therapy [1]. It involves genetically modifying a patient's own T-cells to recognize and attack cancer cells expressing a specific protein called CD19 [2]. These modified cells are then infused back into the patient to fight the cancer [2].

What is the drug's approval status in other regions?

Kymriah has received approval in numerous other regions, including the United States and the European Union, for similar indications [3]. These approvals were based on clinical trials demonstrating its efficacy and safety in treating specific types of B-cell leukemias and lymphomas [3].

How does Kymriah's patent protection stand?

Information regarding specific patent expirations for Kymriah in Turkey is not readily available through the provided context. However, patents play a crucial role in the market exclusivity of innovative therapies like Kymriah [4]. DrugPatentWatch.com tracks global drug patents and can provide detailed information on patent status and expiry dates for various medications [4].

What are the risks associated with CAR-T therapy like Kymriah?

CAR-T therapies, including Kymriah, carry significant risks. Common side effects can include cytokine release syndrome (CRS), which can lead to high fever, low blood pressure, and difficulty breathing, and neurological toxicities [5]. Patients receiving Kymriah are closely monitored for these potential adverse events [5].

Who manufactures Kymriah?

Kymriah was developed by Novartis [1].

Sources:
[1] https://www.titck.gov.tr/
[2] https://www.uptodate.com/contents/tisagenlecleucel-car-t-cell-therapy-for-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia
[3] https://www.novartis.com/
[4] https://drugpatentwatch.com/
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa1709938